Self-policing could stem the heartbreaking wave of unnecessary cardiac procedures

Indiana electrophysiologist Scott Kaufman first encountered Gloria Sargent seven years ago in the emergency department of Community Healthcare System in Munster, Indiana. Sargent was vomiting and her heart rate was out of control.

Years later, Kaufman saw another patient, Angela Webb, who was having difficultly simply picking up her grandson.

In both cases, Kaufman determined that the pacemaker-defibrillator that had been surgically implanted in the patients was completely unnecessary. In fact, once the device was removed, the health concerns that had brought the women to Kaufman in the first place disappeared entirely.

Webb and Sargent are among 293 patients who have filed lawsuits against three cardiologists who comprise Cardiology Associates of Northwest Indiana. Their stories, and the experiences of a handful of other patients, were revealed in a New York Times article last week that cut to the core of fraud allegations that are representative of a larger trend across the country.

What is particularly interesting about the situation in Munster is the way in which it evolved from a few sick patients to hundreds of plaintiffs. Kaufman determined that Sargent and Webb were former patients of Arvind Gandhi, one of the partners at Cardiology Associates, and then began noticing a trend. He eventually saw 15 patients formally treated by Gandhi and determined 11 of them underwent unnecessary procedures.

Then he did something truly unheard of: He teamed up with medical malpractice lawyers, the same ones whom he had faced off with in the courtroom twice before. (Both cases against Kaufmann were settled and a medical review panel absolved him of wrongdoing).

The take-home message of the Times article seemed to be if it can happen in a small Midwestern town, then it can happen anywhere.

Unfortunately, it is happening everywhere. This year alone, we've seen dozens of indictments and settlements involving cardiologists, or hospitals that either turned a blind eye or were simply too distracted by the pumped-up reimbursement to pay much attention. In June, a New York hospital paid $18.8 million to settle allegations of unnecessary cardiac procedures. In September, an Ohio cardiologist was convicted of billing Medicare $7.2 million in unnecessary procedures, and a Kentucky cardiologist pleaded guilty to performing unnecessary cardiac stents at Kings Daughters Medical Center, which paid $40 million last year to settle fraud allegations tied to cardiac procedures. Also in June, one of the highest-paid physicians in the country was banned from Medicare after being hit with lawsuits for unnecessary cardiac procedures. And earlier this year, a three-year-old lawsuit was unsealed alleging unnecessary cardiac procedures in one of the largest health systems in the country.

The issues surrounding the sudden glut of unnecessary cardiac procedures are three-fold. First, reimbursement for cardiac surgery is the highest of any other procedure, which, as many have pointed out, serves as the motivation for unnecessary procedures. In this case, money serves as both a motivator and a distraction.  

Second, the guidelines surrounding the necessity for cardiac procedures, such as stents and pacemakers, are somewhat nebulous, so much so that the American College of Cardiology has published dozens of "Appropriate Use Criteria," including pacemakers, stents and diagnostic catheterization. These, however, are merely guidelines, and the procedures themselves still include an element of physician judgement.

Finally, unnecessary procedures are just too difficult to identify from a fraud-prevention standpoint. Certainly physicians with high reimbursement rates will invite scrutiny, but there may be multiple factors at play, including geographic location (for instance, one surgeon may get the majority of referrals in a rural area). Claims data can be a starting point, but targeting every highly paid cardiologist would be like accusing everyone with a Lexus of carjacking.  

In Munster, Indiana, the full impact of unnecessary procedures didn't come to light until another physician was able to identify a troubling trend. Moreover, patients had to endure the adverse consequences of unnecessary stents and pacemakers for years before there was any indication this was a problem. Even now, the Times notes that each of the 293 cases needs to be examined by a medical review panel, a process that can take years.

The issue of unnecessary cardiac procedures has been building momentum for years, and fraud investigators are certainly well aware of the amount of federal dollars that circle the drain thanks to the trend. The problem is, claims data alone can't identify whether a procedure is necessary or not. Earlier this year, Ken Harvey, U.S. Attorney for the Eastern District of Kentucky, told U.S. News and World Report that his office retains cardiologists to review suspect claims, but added that infringing on physician judgement means walking a fine line.

"We steer a wide berth around medical judgment," he told U.S. News. "If it's close, we're going to give [physicians] the benefit of the doubt."

With unnecessary cardiac procedures emerging as a growing and expensive concern, it will be interesting to see how investigators toe that line, and whether cardiologists like Kaufman will take on a larger role in self-policing their specialty. - Evan (@HealthPayer)